Suturing means for connecting a tubular vascular prosthesis to a blood vessel in the body in addition to branch means, a vascular prosthesis, a device for inserting and suturing a vascular prosthesis in the body, and a vascular prosthesis system

ABSTRACT

Suturing means and branch means, a vascular prosthesis, a device and a vascular prosthesis system. Suturing means for connecting a vascular prosthesis ( 40 ) to a blood vessel ( 50 ) comprise an internal, substantially annular body ( 10 ) intended to be received in the blood vessel ( 50 ) in addition to an external annular body ( 20 ) intended to lie clampingly on an outer wall of the blood vessel ( 50 ) at least practically at the location of the internal annular body ( 10 ). At least one of the two annular bodies ( 10, 20 ) is provided with suturing members ( 12 ) which grip in the vessel wall so as to effect an adequate fixation of at least the internal annular body ( 10 ). The invention also provides a device for use with such suturing means and further relates to a vascular prosthesis which is provided on at least one of its outer ends with at least a part of such suturing means. Different embodiments of such prostheses together form a modular vascular prosthesis system. A side vessel of thus supported blood vessel can be preserved using branch means according to the invention.

The present invention relates to suturing means for connecting a tubularvascular prosthesis to a blood vessel in the body.

The invention herein relates particularly, but not exclusively, tovascular prostheses intended to replace or support the natural vesselwall of particularly the aorta. Due to damage or other weakening of thewall thereof a dilation, a so-called aneurysm, can result locallyherein. If timely action is not taken the vessel wall can eventuallyrupture at the location of such an aneurysm, resulting in internalbleeding and therewith a life-threatening situation. To avoid this theexisting vessel wall is either replaced or covered with a suitablevascular prosthesis at the location of the aneurysm.

A traditional method of arranging such a vascular prosthesis consists ofopening the abdominal wall from the sternum to the pubis, whereafter anincision is made along the full length of the blood vessel at thelocation of the unhealthy part. A suitable vascular prosthesis in theform of a tubular body of circular knitted textile of a similar diameterand length is subsequently sutured to the healthy ends of the bloodvessel with suture needle and thread. The affected vessel wall is thenpreferably placed round the vascular prosthesis and subsequently closed.

It will be apparent that the above specified method involves a majoroperation which in practice can require more than three hours. Even moreimportant than the total duration of the operation however is that theblood flow in the vessel has to be interrupted for a relatively longtime, of sometimes more than an hour. This involves a serious danger ofcomplications both during the operation and thereafter. It will moreoverbe apparent that the stated size of the operation wound in thisoperating method also results in a relatively great discomfort for thepatient and adversely affects his recovery. There is also the risk of acertain leakage through the suture, so-called false aneurysms, which mayin such cases necessitate the operation being repeated.

In order to obviate these drawbacks an alternative operation techniquehas been developed, wherein a vascular prosthesis is arranged at thedesired location endovascularly, i.e. via the vascular system itself.Such an endovascular prosthesis generally comprises a tubular body, thewall of which is formed by a metal scaffold which is resilient andcapable of expanding in radial direction. The endo-prosthesis isarranged in compressed state on a tip of a catheter and manoeuvred withthe catheter via a relatively small incision in the groin or anothersuitable place to the weakened part of the blood vessel for treating.Having arrived at the desired location, a temporary envelope is pulledoff the prosthesis or a balloon incorporated in the prosthesis isexpanded, whereby the prosthesis expands from the compressed to anexpanded state, wherein the prosthesis lies resiliently against an innerwall of the blood vessel. Initially only the expansion force of theprosthesis holds the prosthesis in its place, but in the course of timebodily tissue will be deposited on the prosthesis whereby in the longterm it will ideally be completely embedded in the wall of the bloodvessel.

Such an endovascular method undeniably entails less discomfort for thepatient than the classical operating method and the circulation of bloodthrough the blood vessels also remains largely undisturbed.Nevertheless, this method also has drawbacks. Apart from the relativelyhigh cost of this treatment there is the drawback that the suturing ofthe prosthesis to the blood vessel is effected initially solely by theradial spring force of the prosthesis. There is a therefore a realdanger that the prosthesis can be entrained to a greater or lesserdegree by the blood flow. This danger is acknowledged in an example of aknown endovascular prosthesis which is described in the Internationalpatent application no. 97/39687, wherein for this purpose the proximalside of the prosthesis is provided with a ring of fine hooks to anchorthe prosthesis in the vessel wall. Because it must be possible tointroduce the entire unit endovascularly, the dimensions and therewiththe anchoring of these hooks are inevitably limited.

There is however also the risk that the blood will be able to find itsway between the wall of the blood vessel and the prosthesis and thenstill exert the original pressure on the vessel wall. Such a case isreferred to as an endo-leak. To remedy such a complication an operationin the traditional manner will still have to be performed, whereby alladvantages of an endovascular treatment method are nullified. In orderto prevent this in the case of the above stated example of a knownendovascular vascular prosthesis, tensioning straps are arranged at thelocation of both the proximal and the distal end of the vascularprosthesis, after it has been introduced, for better fixation of thewhole round the vessel wall. Such a fixation is also described in thecase of the endovascular vascular prosthesis known from the U.S. Pat.No. 5,764,274. However, such tensioning straps cannot be introducedendovascularly so that a classical operation is still required for thispurpose. The tensioning member of the applied tensioning straps moreoverprovides an undesirable irregularity in the body which may adverselyaffect the biocompatibility of the whole.

Finally, as a result of their necessarily fragile construction,endovascular prostheses have been found in practice to be of limiteddurability, whereby for the time being the quality of the prosthesiscannot be fully guaranteed in the long term.

The present invention has for its object to provide suturing means ofthe type stated in the preamble which allow a suturing technique which,compared to the traditional operation technique, entails only relativelyminor surgery for the patient but which, compared to an endovascularmethod, enables a markedly more reliable suturing of the prosthesis tothe vessel wall.

In order to achieve the intended objective, suturing means of the typestated in the preamble have the feature according to the invention thatthe suturing means comprise an internal, substantially annular bodyintended to be firmly connected to an outer end of the vascularprosthesis and to be received in the blood vessel, that the suturingmeans comprise an external annular body intended to lie clampingly on anouter wall of the blood vessel at least practically at the location ofthe internal annular body and that at least one of the two annularbodies is provided with suturing members which at least in connectedsituation thereof extend from the blood vessel substantially radially inthe direction of a vessel wall and grip at least in the vessel wall soas to effect an adequate fixation of at least the internal annular body.

In order to arrange a vascular prosthesis it suffices, making use ofsuch suturing means, to make only a small incision in or close to theaffected part of the blood vessel where the vascular prosthesis will besutured to healthy ends of the blood vessel to enable placing of theprosthesis into the vessel. Once the blood vessel has been sufficientlyexposed and this incision made, the vascular prosthesis is introducedvia the incision and optionally shortened to the required length. Theinternal annular body of the suturing means can herein already beincorporated in the prosthesis on an end thereof. The vascularprosthesis is pressed sufficiently far into the blood vessel so that theend with the internal annular body of the suturing means eventually liesat the location of one of the healthy ends of the blood vessel on eitherside of the affected part thereof. The blood vessel is here accessibleto the external annular body of the suturing means which is placedclampingly round the blood vessel at the position of the internalannular body to allow the suturing members to penetrate properly into atleast the vessel wall and thus effect a reliable suturing and sealing ofthe prosthesis on the vessel wall. This procedure is repeated on theopposite side of the weakened vessel part with another end of theprosthesis, whereafter the vessel wall and abdomen are closed again.

It has been found in practice that the suturing means according to theinvention, optionally making use of tools designed therefor such as forinstance the devices which will be further described below, can bearranged within only a few seconds. The operation time, and particularlythe necessary interruption of the natural blood flow through the vesselcan thus be considerably limited when compared to the above specifiedtraditional suturing method, which is of great importance particularlyin the aftercare and recovery of the patient. Because at least thevessel wall is clamped between both annular bodies at the location ofthe suturing means, which thereby provide an effective sealing, thechance of an endo-leak is also drastically reduced, if not completelyeliminated, by the suturing means according to the invention.Furthermore, the prosthesis is adequately fixed to the vessel wall bymeans of the internal annular body, whereby the danger of undesiredshifting of the prosthesis in the blood vessel is likewise prevented, orat least greatly reduced. Because the annular body and the vascularprosthesis are introduced by classical means, no concessions have tomade in their material and construction as in the case of anendovascular insertion technique. The internal annular body cantherefore be relatively robust so as to be able to sufficientlycounterbalance the forces exerted radially thereon by the externalannular body and thus ensure an adequate fixation of the vascularprosthesis. For the prosthesis itself a traditional tubular body can beused per se, the long term durability thereof having by now beensufficiently tested, this in contrast to tubular bodies provided withstents, whether or not self-expanding, applied in endovascular treatmentmethods. The invention nevertheless requires only a small incision andthe operating time, and more particularly the period of time for whichthe bloodstream is blocked, is considerably shorter than in the fullyclassical treatment method, which radically reduces the risk ofmortality and other complications. The invention thus combines theadvantages of both the known methods described above, i.e. relativelyrapid and minimal surgery together with a reliable fixation and sealingof the prosthesis on the vessel wall, without the associated drawbacks.

In a particular embodiment the suturing means according to the inventionare characterized in that the suturing members, at least in theconnected situation, extend radially from a first of the two annularbodies and are received in the other of the two annular bodies to thuseffect a firm mutual connection while enclosing the wall of the vascularprosthesis and the vessel wall. In this embodiment the vessel wall andthe vascular prosthesis are as it were clamped between both parts of thesuturing means, wherein the suturing members provide a through mutualanchoring of the diverse parts. An exceptionally reliable suturing isthus obtained, which owing to the invention can be arranged in anextremely short time.

In a further embodiment the suturing means according to the inventionare characterized in that the first annular body comprises a metal ringwith lips which can be pressed radially outward and are provided withsharp protrusions which are capable of penetrating through the wall ofthe prosthesis, the wall of the blood vessel and into the material ofthe other of the two annular bodies. After the first annular body hasbeen brought into position, the lips are pressed out with or without theuse of a special accessory so that the sharp protrusions penetrate intothe other annular body. The protrusions are herein preferably providedwith one or more barbed hooks to ensure their fixation in the materialof the other annular body.

A preferred embodiment of the suturing means according to the inventionhas the feature that the suturing members extend from the internalannular body and that the external annular body comprises at least acore of plastic for receiving the suturing members therein. Because thesuturing members herein extend from the internal annular body and passthrough the vessel wall to the outside to be received in the otherannular body, the internal annular body can be relatively thin, wherebythe natural blood flow is thereby disturbed as little as possible. Inthis respect an inner diameter is preferably chosen for the internalannular body which is equal to that of the original blood vessel and theblood vessel is slightly stretched to allow nesting of the annular bodytherein so that no turbulences or other disturbances whatsoever arecaused in the blood flow. A visual inspection is thus further possibleto establish that the normally sharp ends of the suturing member areactually lying in the other annular body and not outside it. Preferablyapplied herein is a tough or foamed plastic which allows for arelatively easy penetration of the suturing members and then firmlyfixes the suturing members.

To enable a simple positioning of the external annular body round theblood vessel, a further particular embodiment of the suturing meansaccording to the invention has the feature that the external annularbody comprises a ring which is interrupted in at least one position andthat at the location of the interruption closing means are provided tomutually connect adjacent ring parts. The blood vessel is hereininserted in the opened ring, whereafter the ring is closed using theclosing means. The closing means for instance comprise a suturing memberwhich extends from one of the two ends of the annular body and iscapable of penetrating in fixing manner into the material of the otherend. More particularly the closing means are adjustable so that theexternal body can be clamped and closed tightly round the internal one.

In a preferred embodiment the suturing means according to the inventionhave the feature that the external annular body comprises at least on aside facing the blood vessel a regular pattern of cams with which thebody supports on the blood vessel, which cams leave mutually freeinterspaces extending over the full width of the body. Because in thisembodiment at least one of the two annular bodies does not support onthe blood vessel wall along its full surface but only with a regularpattern of cams between which channels remain clear, the blood vesselwall is prevented from being completely clamped off by the suturingmeans whereby the blood circulation therethrough could be endangered andthe blood vessel wall could die off. The channels formed by thecontinuous interspaces effectively prevent this.

The prosthesis, preferably already provided with the internal annularbody, is inserted into the blood vessel with a suitable tool. Foradequate fixing herein of the internal annular body located inside theprosthesis a further particular embodiment of the suturing meansaccording to the invention has the feature that the means also comprisea clamping ring which is intended to lie against an outer wall of theprosthesis at least practically at the position of the internal annularbody and herein exert at least locally a radially inward directed force.More particularly the clamping ring herein comprises a crimp ring whichcan permanently decrease in diameter at increased temperature. Afterspecified heating such a ring crimps around the prosthesis havingtherein the internal annular body of the suturing means, so that theprosthesis is clamped between the two. This ensures an adequate fixationof the internal body in the prosthesis.

In a further particular embodiment the suturing means according to theinvention have the feature that the suturing members compriseprotrusions which extend from the internal annular body on a sidethereof directed toward the blood vessel wall and are capable, at leastunder the influence of a radially directed force, of penetrating atleast partially the blood vessel wall to thus anchor the prosthesistherein. More particularly the suturing members herein comprise aregular pattern of crater-like openings, the walls of which form theprotrusions. It is not necessary herein for the suturing members topenetrate completely through the vessel wall in order to penetrate forinstance into an external annular body. An adequate gripping in thevessel wall will already suffice. This embodiment is herein based on theinsight that in the bloodstream mainly axial forces will be exerted onthe suture and not much in the way of radial forces, whereby an axialanchoring such as by means of the suturing members referred to here isin itself sufficient. The external annular body is able to provide thecounterpressure possibly required herein at the moment the suturingmembers penetrate into the vessel wall. Furthermore, the external bodywill in this case also prevent the occurrence of possible endo-leaks,now that it can be placed tightly round the internal body whileenclosing at least the vessel wall.

A further particular embodiment of the suturing means herein has thefurther feature according to the invention that the internal annularbody has an inner diameter which is at least practically equal to anouter diameter of the vascular prosthesis and that the internal annularbody is intended to lie against an outer wall of the vascularprosthesis. The internal annular body can be fixed by means of asuitable glue or otherwise on the outer wall of the vascular prosthesis,so that the protrusions do not have to be pressed through the prosthesiswall and can thereby be shorter. This reduces the chance of damage tothe inner wall of the blood vessel during an operation, wherein aprosthesis provided with such an annular body is guided to the desiredlocation via the blood vessel.

To further reduce this risk and also to enable insertion of the whole insimple manner in a blood vessel, a further embodiment has the featureherein that the internal annular body comprises a deformable ring whichin a first contracted state has a diameter which falls within thediameter of the blood vessel and in a second expanded state is able tolie against an inner wall of the blood vessel. In the first contractedstate the deformable ring, lying round the vascular prosthesis, can beinserted without difficulty into the blood vessel and manoeuvred to thedesired position. There the ring is expanded to the full diameter sothat the ring eventually lies against the vessel wall and the suturingmembers penetrate therein. This can be realized in a very short time andin particularly reliable manner making use of a special tool such as thedevice to be further described hereinbelow, so that here also theunavoidable disruption of the natural blood circulation during theoperation is limited.

In a conventional operating method side vessels of a blood vessel areusually lost at the location of a vascular prosthesis arranged thereinbecause such side vessels are closed off by the vascular prosthesis. Theinvention also provides, on the basis of the same principle as the abovespecified suturing means, branch means for connecting a side vessel of amain blood vessel to a vascular prosthesis arranged in the main bloodvessel, which branch means make it possible to preserve a possible sidevessel. According to the invention such branch means comprise aflange-shaped internal body intended to lie against an inner wall of thevascular prosthesis, which flange-shaped body carries on its sidedirected toward the vascular prosthesis a hollow stem open on both sidesas well as at least one suturing member, both of which are able topenetrate through the wall of the vascular prosthesis, and comprise aflange-shaped external body intended to lie round the side vesselagainst an outer wall of the main blood vessel at the position of theinternal body, which external body is provided with a bore for receivingthe side vessel and the stem therein, wherein at least in mutuallyconnected state the suturing member is received in the externalflange-shaped body, thus forming a firm mutual connection, and the stemis received in the side vessel, thus forming an open connection betweenthe main blood vessel and the side vessel. The internal body is hereinpressed through the prosthesis wall as a kind of thumbtack with the stemand the at least one suturing member, wherein the stem is carried intothe side vessel. The at least one suturing member penetrates adjacentlyof the side vessel through not only the prosthesis but also the vesselwall. The external body is placed round the side vessel and pressedfirmly together with the internal body so that the suturing memberpenetrates in the material of the external body and thus effects a firmconnection. In this manner the hollow stem provides an opencommunication between the prosthesis in the main blood vessel and theside vessel, which latter is thus preserved.

In a preferred embodiment of the branch means the stem tapers to a pointat its free end in order to facilitate penetration thereof through theprosthesis wall. Although for the mutual connection of the twoflange-shaped bodies a single suturing member will optionally suffice, apreferred embodiment of the branch means has the feature that theinternal body comprises at least two suturing members which are disposedaround the stem. For the purpose of simple positioning of the externalbody a further preferred embodiment of the branch means according to theinvention has the feature that the external disc-like body comprises achannel which provides access to the bore from a peripheral edge. Theside vessel can herein be inserted in the bore in simple manner via thechannel.

The invention also relates to a device for inserting and suturing aflexible tubular vascular prosthesis in the body, which prosthesis isprovided on a free end with an annular body which lies against a wallthereof, comprising a flexible infeed line, which infeed line isprovided on one end with a fixation member intended for receivingthereon the vascular prosthesis with the internal annular body, whichfixation member is able when energized to exert a radially outwarddirected force on the annular element.

The prosthesis is pushed into the affected blood vessel making use ofsuch a device using the flexible infeed line, wherein the fixationmember holds the prosthesis precisely in place. At the intended locationthe fixation member is energized to thus press the prosthesis with theannular body radially outward. The prosthesis with the annular elementis thus pressed from the inside against the vessel wall, which hereinpreferably receives a counterpressure from outside in the form of asecond annular body forming part of the suturing means according to theinvention and arranged round the blood vessel at that position. Owing tothe action of said force the suturing members provided on at least oneof the two annular bodies will be able to adequately penetrate at leastthe vessel wall and thus achieve a reliable fixation of the vascularprosthesis.

In a particular embodiment the device according to the invention has thefeature that the annular body comprises a metal ring with suturingmembers which can be pressed radially outward and that the fixationmember is able to exert a radially outward directed force on at leastthe suturing members of the annular body. In this embodiment the radialforce is not so much exerted on the annular body as a whole but morespecifically on the outward pressable suturing members which therebypenetrate into or even through the vessel wall.

A further particular embodiment has the feature herein that the suturingmembers comprise lips with sharp ends which are retracted and can bepressed radially outward and that the fixation member comprises arotatable disc for receiving the annular body thereon, which disc isprovided with recesses for receiving the lips of the annular bodytherein. In this embodiment the suturing members are formed by outwardpressable lips which are initially directed inward and therefore lie atleast partially retracted in the ring. The retracted lips herein fallinto the recesses of the disc and will be forced radially outward whenthe disc is rotated and the lips are herein driven out of the recesses.Such a retracted positioning facilitates insertion of the prosthesisprovided with the annular body and prevents unintentional damage to thevessel wall during transport to the suturing location. At the intendedlocation the lips are forced out of the respective recesses byappropriate rotation of the disc. All lips will thus penetrate withtheir sharp end at least almost simultaneously at least into the vesselwall to effect the desired suturing.

In order to prevent the annular body co-rotating under the influence ofthe rotation of the disc, a further particular embodiment of the deviceaccording to the invention has the feature that the fixation membercomprises two discs which are rotatable in opposing directions and aremutually adjacent and which together receive the annular body thereon,which discs are both provided with recesses for receiving therein lipsof the annular body which are retracted in opposing directions and whichcan be pressed radially outward. By thus performing two rotations inopposing directions in the fixation member which act upon the internalannular body, at least practically no net force is exerted thereon sothat possible co-rotation of the annular body is prevented. This isparticularly important if the suturing members of the annular body haveto be received at a precisely determined location in for instance asecond annular body which has been arranged externally round the vesselwall.

In a further particular embodiment the device according to the inventionhas the feature that the fixation member comprises an inflatable bodywhich in a first at least partially evacuated state can be received inthe prosthesis with the annular body and in a second filled state takeson a cylindrical form coaxially with the prosthesis, an externaldiameter of which is at least practically equal to an internal diameterof the vascular prosthesis. Such a fixation member has a relativelysimple mechanical construction and is found in practice to havesufficient expansion force to press the vascular prosthesis with theannular body sufficiently firmly from the inside against the vessel wallto thus enable suturing members to at least penetrate adequatelytherein.

In order to avoid overloading of the vessel wall herein and retain fullcontrol over the expansion behaviour of the inflatable body, a preferredembodiment thereof has the feature according to the invention that inthe second state the inflatable body is at least practically non-stretchand herein maintains an internal pressure in the order of magnitude ofseveral tens of atmospheres. In inflated form such a fixation memberbehaves as a rigid and practically non-compressible body which isthereby highly suitable for absorbing and compensating possiblecounterpressure on the suturing members. In evacuated state such afixation member is in contrast flexible and yielding, whereby togetherwith or without a prosthesis arranged thereon it allows of exceptionallyeasy manoeuvring via the blood vessel to the desired location.

A further embodiment of the device according to the invention has thefeature that the device comprises a second fixation member intended forfixing a second annular body, which second annular body is intended forlying against an outer wall of a blood vessel and that monitoring meansare provided for indicating the mutual position of both fixationmembers. The second annular body is placed round the blood vessel withthe second fixation member at a location which corresponds preciselywith that of the first internally arranged annular body on the firstfixation member. To enable adequate control of this relative position,the monitoring means provide an accurate indication of the mutualposition of both fixation members and therewith of both annular bodies.A precise alignment of the respective positions of both annular bodiescan thus be realized in simple manner. The suturing members of at leastone of the two bodies can subsequently be driven into at least thevessel wall to thus ensure an adequate enclosing and anchoring of thevascular prosthesis on the vessel wall.

The invention further relates to a vascular prosthesis comprising aflexible tubular body intended to be connected to a blood vessel with afirst and a second end respectively at a first and a second location.

In order to enable such a vascular prosthesis making use of the suturingmembers and device according to the invention to be arranged in the bodyof a patient in a short time, such a vascular prosthesis according tothe invention has the feature that the tubular body comprises an openingin a wall thereof between the first and second end. This openingprovides a passage for the suturing means and device according to theinvention for realizing therewith said connections at the first andsecond location. After the first end of the prosthesis has been sutured,the second or further end of the prosthesis can be fixed in similarmanner from the inside via the opening in the prosthesis. Following thisoperation the opening in the prosthesis is closed and the vessel wallsutured at this location, whereafter the bloodstream can resume itsnatural flow. To facilitate closing of the prosthesis a preferredembodiment thereof has the feature according to the invention that thetubular body comprises an externally directed collar around the opening.In such an embodiment only the collar has to be closed to close theprosthesis adequately. For this purpose a lace can for instance beprovided in the collar with which the collar can be laced up, althoughsuch a collar can also be closed extremely quickly in other manner, suchas for instance by means of stapling.

A further vascular prosthesis comprising a flexible tubular body, atleast a first end of which is intended for connecting to a blood vesselhas the feature according to the invention that the tubular body isprovided on at least the first end with an internal annular body of thesuturing means according to the invention. A first particular embodimentof such a prosthesis according to the invention, wherein the internalannular body lies against an inner wall of the tubular body, has thefeature herein that a clamping ring lies clampingly on an outer wall ofthe tubular body at the location of the internal annular body. A secondparticular embodiment of such a prosthesis according to the inventionhas the feature herein that the internal annular body lies on an outerwall of the tubular body via a suitable glue connection. Such prosthesesare ready for immediate use at least on the relevant end and can besupplied including the relevant parts of the suturing means in asterilized packaging, which saves (preparation) time during theoperation.

A further preferred embodiment of the vascular prosthesis according tothe invention has the feature that a second end of the tubular body isprovided with coupling means which are capable of a liquid-tightcoupling to a free end of a second flexible tubular body. Moreparticularly this preferred embodiment according to the invention ischaracterized in that the coupling means comprise a rigid, tubularcoupling element which is firmly connected on a first side to the secondend of the tubular body and comprises on a second part a taper intendedfor clampingly receiving thereon the free end of the second tubularbody. A rapid coupling can thus be established extremely rapidly betweenboth tubular bodies wherein the free end of the second tubular bodysimply has to be pushed onto the taper. In order to secure thisconnection a further particular embodiment of the vascular prosthesisaccording to the invention is characterized in that the coupling elementis provided at the location of the taper with at least one external,tangentially running rib which extends over at least a part of theperiphery of the taper and more particularly in that the couplingelement comprises at the location of the taper at least two externalribs which leave a certain mutual interspace, which interspace isintended for receiving a clamping ring at that position which fixedlyclamps the end of the second tubular body onto the taper. The free endof the second tubular body is pushed over this rib or ribs onto thetaper, whereafter the rib and optionally the clamping ring keeps thesecond tubular body from sliding off unintentionally.

A prosthesis provided with such coupling means can be sutured on thefirst end to a healthy end of the blood vessel in the above describedmanner, while the second end provides the option of a liquid-tight rapidcoupling to another, possibly similar vascular prosthesis. It is herebyunnecessary to perform a second or further suturing from the inside ofone and the same prosthesis, and the sutures can be placed independentlyof each other and the different free ends can be mutually connected bymeans of the coupling means described here. Not only can additional timebe gained in practice due to such a rapid coupling, but the possibilityis also provided of a modular construction of a vascular prosthesissystem of mutually connectable prosthesis elements, to which prosthesissystem the invention therefore also relates. In addition to singleprosthesis elements with only a main leg which is arranged on eitherside between healthy ends of the affected blood vessel, this vascularprosthesis system for instance also comprises more complex elementswhich are adapted in respect of design to specific surgery.

A particular embodiment of the vascular prosthesis according to theinvention provides as such a module which is specifically suitable forrealizing a so-called end-to-side anastomosis. This particularembodiment of the vascular prosthesis has the feature that the tubularbody comprises a main leg, between opposite ends of which at least oneside leg extends, and that at least one of the free ends of the tubularbody carries either an internal annular body associated with thesuturing means according to the invention or coupling means of the abovespecified type. More particularly this embodiment has the feature thatthe main leg is provided on either side with such an internal annularbody. In this embodiment the main leg can be fully inserted into ahealthy blood vessel and fixedly sutured therein on either side in theabove described manner. The at least one side leg of the prosthesis thenprovides a branch of this blood vessel and can be sutured, eitherdirectly or via the above specified coupling means and a furthervascular prosthesis, to an end of a further blood vessel, thus realizingan end-to-side anastomosis.

Another particular embodiment of the vascular prosthesis according tothe invention is characterized in that the tubular body comprises aprimary leg with a first free end and a second end which divides into atleast two secondary legs and that at least one of the free ends of thetubular body carries either an internal annular body associated with thesuturing means according to the invention or coupling means of the abovespecified type. This embodiment is eminently suitable and therebyprovides appropriate modular elements of the prosthesis system accordingto the invention for the purpose of a so-called end-to-end anastomosis,particularly one close to the bifurcation, wherein a healthy end of ablood vessel must be connected to usually two other healthy ends ofblood vessels.

For the complete replacement or support of a bifurcation of the chest orstomach aorta, a particularly practical embodiment of the vascularprosthesis herein has in this respect the feature according to theinvention that the primary leg is provided on the first end with aninternal annular body and that the secondary legs each carry couplingmeans on their free end. The primary leg is herein sutured to a healthyend of the aorta, while the secondary legs are coupled to healthy endsof the arteries branching therefrom via single prostheses which can eachbe individually shortened to the desired length.

Suitable for a more general end-to-end anastomosis and smallerbifurcations is a further particular embodiment of the vascularprosthesis according to the invention which is characterized in that atleast the secondary legs are each provided at their free end with aninternal annular body. These secondary legs can be sutured according tothe invention directly to the branches of a blood vessel which is itselfcoupled to the primary leg either directly or via a further vascularprosthesis according to the invention.

The invention will now be further elucidated and explained on the basisof a number of embodiments and an associated drawing which furtherillustrate the invention but do not in any way limit the invention inits range and scope. In the drawing:

FIGS. 1A-1C show a perspective view of a first embodiment of thesuturing means according to the invention;

FIG. 2 shows a longitudinal section of a first embodiment of the deviceand a vascular prosthesis according to the invention;

FIGS. 3A-3B show two cross-sections of the device of FIG. 2 insuccessive stages of operation;

FIGS. 4A-4C show different cross-sections of an embodiment of branchmeans according to the invention;

FIGS. 5A-5B show in perspective view a second embodiment of suturingmeans and a vascular prosthesis according to the invention;

FIGS. 6A-6B show a perspective view of a second embodiment of a deviceaccording to the invention;

FIG. 7 is a perspective view of a further embodiment of a vascularprosthesis according to the invention which forms a vascular prosthesismodule forming part of an embodiment of a vascular prosthesis systemaccording to the invention;

FIGS. 8A-8B show a detail drawing in cross-section of a rapid couplingwith an embodiment of the vascular prosthesis according to theinvention; and

FIGS. 9-12 show a perspective view of further embodiments of a vascularprosthesis according to the invention which each form a vascularprosthesis module forming part of the embodiment of the vascularprosthesis system according to the invention.

The figures are purely schematic and not drawn to scale. Some dimensionsin particular are (highly) exaggerated for the sake of clarity.Corresponding components are designated as far as possible in thefigures with the same reference numerals.

The suturing means of FIGS. 1A-1B comprise an internal annular body 10,see FIG. 1A, in the form of a closed ring of high-grade steel or anotherbiocompatible metal or metal alloy. Arranged in the wall of the ring atregular positions are notches 11 which provide space for suturingmembers 12. The suturing members here comprise a regular pattern of lips12 with sharp protrusions 13. The lips are initially retracted radiallybut in the shown situation are pressed radially outward, in which caselips 12 are able to penetrate through the vascular prosthesis and thevessel wall, which will be further elucidated hereinbelow.

The suturing means further comprise an external annular body 20, seeFIG. 1B, in the form of a ring with at least a core of plastic. In thisembodiment the ring is wholly manufactured from a plastic and with asufficient thickness such that ring 20 can receive suturing members 12therein in clamping and snapping manner, so that a reliable gripping andmutual connection is effected. Other than the internal body, externalring 20 does not comprise an integral unit but ring 20 has aninterruption 21 where closing means are provided to hold togetheradjacent ring parts. The closing means here comprise a snap member 22which snaps precisely into a complementary bore 23 in the adjacent ringpart, this being shown in more detail in the indicated circle. Ifdesired, more of such snap members can be provided so that ring 20 isadjustable and can be adapted to the actual dimensions of the bloodvessel. Ring 20 can thus be opened and closed manually. Ring 20comprises on its inner side a regular pattern of cams 24, whereby ring20 is able to support on an outer wall of a blood vessel while leavingclear interspaces 25. The interspaces 25 extend over the full width ofring 20 and thus provide continuous channels which ensure sufficientblood circulation through the vessel wall to prevent undesired dying offthereof.

The suturing means of this embodiment further comprise a clamping ring30, see FIG. 1C. The clamping ring here comprises a crimp ringmanufactured from a suitable crimp foil of plastic and is therefore nomore than an extremely thin band which is nevertheless capable ofexerting a substantial radially inward directed force when it ispermanently reduced in diameter at increased temperature.

In order to suture a vascular prosthesis to a blood vessel in the bodymaking use of such suturing means, an incision is made therein at theposition of or close to the affected part to be replaced or supportedafter the blood vessel has been exposed over a sufficient length,wherein a length of no more than a few centimeters usually suffices. Viathis incision the vascular prosthesis is inserted into the blood vessel,for instance using the embodiment of the device according to theinvention shown in FIG. 2.

The device shown in FIG. 2 comprises a hollow, flexible infeed line 101which is provided at one end with a fixation member 102 which isintended for receiving the vascular prosthesis thereon. Vascularprosthesis 40 is herein provided on a free end with the above describedinternal annular body 10 which lies against an inner wall of prosthesis40. The above specified crimp ring 30 holds prosthesis 40 and internalring 10 firmly together. The retracted suturing members 12 of internalring 10 fall into corresponding recesses in a rotatable disc 103,104forming part of fixation member 10, see also FIGS. 3A and 3B. In thisembodiment the fixation member comprises two such discs 103,104 whichrotate in mutually opposing directions, driven herein by separate driveshafts 105 respectively 106 which are guided thereto via the hollowinfeed line. Owing to this retracted position of the suturing membersthe whole of prosthesis 40, inner ring 10 and crimp ring 30 are properlyfixed on fixation member 102.

Lying on fixation member 102 the prosthesis 40 is guided with infeedline 101 into the weakened or at least affected blood vessel 50 via arelatively small incision 51 arranged herein which must be just largeenough to enable passage of fixation member 102. At the intendedlocation the above specified external annular body 20 is placed roundblood vessel 50. The device can optionally be provided herein with asecond fixation member to thereby fix this external annular body 20 ontovessel wall 50, wherein monitoring means are moreover optionallyprovided which indicate the mutual position of both fixation members soas thus to be certain that both annular bodies 10,20 lie opposite oneanother in sufficiently precise manner.

In this situation both discs 103,104 in the first fixation member arerotated a small turn in opposite directions from outside using shafts105,106 so that the initially retracted suturing members 12 of theinternal ring are driven out of the recesses of the discs. The radiallyoutward directed force exerted therein on internal ring 10, or at leaston suturing members 12 thereof, ensures that suturing members 12 areraised and penetrate through prosthesis 40, crimp ring 30 and vesselwall 50 and are thus received in the material of external ring 20, seealso FIGS. 3A and 3B which show the situation respectively before andafter this rotation. Barbed hooks 14 on sharp ends 13 of the suturingmembers herein ensure an effective connection practically free of playto outer ring 20. Each of the suturing members 12 on inner ring 10 thuspenetrates at the same moment into outer ring 20 whereby an extremelyreliable connection is established to the outer ring. The rotation ispreferably performed by means of a pistol-like mechanism on the end ofdrive shafts 105,106 whereby the rotation, and therewith the suturing ofthe vascular prosthesis, can be performed extremely accurately in afraction of a second. The opposing rotation direction of the two discsherein ensures that at least practically no net tangential force isexerted on the internal ring and the vascular prosthesis, so that theseremain accurately in place.

Once the operation has been thus performed on this side of the vascularprosthesis, it is repeated on the opposite side. In order herein toprovide passage to infeed line 101 with fixation member 102 the vascularprosthesis is itself also provided according to the invention with anopening 41 between both ends. As soon as the second suture has also beenmade in similar manner, fixation member 102 is removed and this opening41 in vascular prosthesis 40 is closed. So as to simplify this, thevascular prosthesis according to the invention comprises an externallydirected collar 42 which can be simply closed by stapling or closed in ashort time using a lace or the like. Finally, the incision 51 made inthe vessel wall is sutured, whereafter the bloodstream can resume itsnatural flow. The patient is now ready for further post-treatment,wherein inter alia the skin is closed, and subsequent recovery from theoperation. As a result of the invention the entire operation all in allrequires markedly less time than a more conventional operating techniquewherein a suture is placed manually to stitch the prosthesis and theblood vessel together, wherein particularly the necessary interruptionof the blood flow can be considerably shorter owing to the invention.The clamping enclosure of vessel wall 50 between internal ring 10 andexternal ring 20 moreover reduces the chance of so-called falseaneurysms or endo-leaks which in some cases of said conventionalsurgical respectively endovascular operating techniques may afterwardcompletely negate the result of the operation.

In a conventional operation technique small side vessels of the bloodvessel will normally be closed off by the prosthesis whereby thecirculation to the organs supplied thereby will be obstructed and theseorgans can become inactive in the course of time or can even die off.The invention does however provide a possibility of preserving thecirculation via such side vessels in the form of branch means based onthe same suturing principles as the above specified suturing means. Anumber of embodiments thereof is shown in FIGS. 4A-4D.

The branch means drawn in FIG. 4A comprise a flange-shaped internal body60, see FIG. 4C, which is intended for lying against an inner wall ofmain blood vessel 50, as shown in FIG. 4A. Body 60 is manufactured froma high-grade biocompatible material, for instance a high-gradeform-retaining plastic, steel or other metal or metal alloy, and canoptionally be embodied slightly curved to allow flange 61 to connectbetter onto the radius of blood vessel 50. On one of its two sides thebody 60 carries a hollow stem 62 open at both ends which is able topenetrate through prosthesis 40. Stem 62 in this case tapers slightly onits outer end and thus forms a mandrel facilitating various aspects.Four suturing members 63 stand on the flange around mandrel 62.

The branch means further comprise an external flange-shaped body 70, seealso FIG. 4C, which lies on the outside of main blood vessel 50 againstthe vessel wall thereof. External body 70 is manufactured from a plasticwhich allows a penetration of suturing members 63 therein. The externalbody comprise a through-bore 71, in which side vessel 52 is received viaa radially running channel 72.

In order to make a branch the internal body 60 is pierced through theprosthesis wall from inside, wherein both suturing members moreoverpenetrate straight through the vessel wall and are pressed into theexternal body. The barbed hooks on the ends of the suturing membersherein ensure a strong suturing in the material of external body 70 sothat a reliable connection is established. Hollow stem 62 hereinpenetrates into side vessel 52 and thus makes an open connection betweenmain blood vessel 50 having prosthesis 40 therein on the one side andside vessel 52 on the other. Via this connection a proper bloodcirculation through the side vessel is ensured, whereby the circulationto the organs supplied thereby can be fully retained. In similar mannerpossible other side vessels can if desired also be very quicklyconnected to the prosthesis.

An alternative embodiment of such branch means is shown in FIG. 4B. Inthis case stem 62 of first body 60 does not taper, but retains the sameinner diameter over its entire length to limit the blood flow as littleas possible. A separate mandrel 65 is used to force a perforation inprosthesis wall 40 for stem 62. In preference the body 60 is hereinalready situated on the mandrel, which is removed afterward. Thisembodiment of the branch means is further the same as that in FIG. 4A,i.e. the fixation is here also brought about by an anchoring in externalbody 70.

The embodiment of the branch means shown in FIG. 4D provides fixation ina different way. In this case the stem 62 of internal body 60 comprisesat least on its outer end a number of separate fingers which allow aradial movement. On one end thereof are situated one or more suturingmembers, in this case in the form of barbed hooks 66, which are able topenetrate the vessel wall of the side vessel. For instance using mandrel65 said fingers are driven apart after the body is positioned. Ifdesired, mandrel 65 can be specifically designed for this purpose, forinstance with a local, gradual thickening which drives the fingers apartas mandrel 65 is pulled out of stem 62. An anchoring can thus berealized in side vessel 52, which renders unnecessary a furtheranchoring in main vessel 50 as in the embodiments of FIGS. 4A and 4B. Asignificant advantage here is that the vessel wall does not have to befully perforated and that an in principle foreign external body 70 suchas used in the other embodiments can be omitted.

A second embodiment of the suturing means and vascular prosthesisaccording to the invention is shown in FIGS. 5A and 5B. In thisembodiment vascular prosthesis 40 is already provided on the end whichhas to be connected to the blood vessel with an internal annular body 10with suturing members 12 forming part of the suturing means. Other thanin the first embodiment of the suturing means, the internal annular bodyhere lies on an outer wall of vascular prosthesis 40 and suturingmembers 12 here penetrate only partially into the vessel wall instead ofright through it into an external annular body. In this embodimentannular body 10 has for this purpose an inner diameter which ispractically equal to an external diameter of vascular prosthesis 40 andis fixed thereon via a glue connection.

The suturing members are formed by a regular pattern of crater-likeopenings 14 in the wall of internal body 10, the relatively sharp walls15 of which form protrusions which are capable of entering the vesselwall under the influence of a radially outward directed force action tothus anchor in the vessel wall the body with the vascular prosthesisfixed thereon. The biocompatible materials for the diverse componentsare here also carefully chosen, wherein for the internal body high-gradesteel is used in which openings 14 are punched. The punched edgeunavoidably occurring herein forms the wall 15 of the thus obtainedcrater-like shape of opening 14.

To facilitate insertion of vascular prosthesis 40 with ring 10 thereon,a relatively thin wall thickness is used here, whereby ring 10 isdeformable and can be crimped to about 60% of its original diameter, seeFIG. 5B. The flexible vascular prosthesis co-deforms herein. In thissituation the whole unit is inserted and expanded at the intendedlocation using for instance a second embodiment of a device according tothe invention. This device is shown in FIGS. 6A and 6B and comprises anexpandable fixation member in the form of an inflatable balloon 200which in evacuated state can be received in crimped ring 10 and vascularprosthesis 40. In this situation the whole unit is inserted into theblood vessel for treating via an incision arranged for this purpose inthe vessel wall. Once prosthesis 40 is situated at the correct locationa suitable medium, either a gas or a liquid, is admitted into balloon200 via a thin flexible infeed line 201, so that it expands togetherwith the vascular prosthesis 40 and ring 10 lying thereon. For thispurpose the infeed line 201 is provided on one end with coupling means202, see FIG. 6B, wherewith a connection can be made in simple manner tomeans for supplying the medium under pressure.

Admitting of the medium is continued until ring 10 has assumed at leastits original shape and protrudes with craters 12 into vessel wall 50.Balloon 200 now has a cylindrical shape with an outer diameter which atleast practically corresponds with the internal diameter of the vascularprosthesis 40. Because a balloon wall is used here which is at leastpractically non-stretch, the vessel wall is prevented from being loadedtoo much should too much air accidentally be admitted. In practice apressure in the order of several tens of atmospheres prevails in balloon200, whereby the balloon behaves as a rigid, non-compressible body whichgives sufficient counterpressure to arrange an external annular bodyround the blood vessel in the above stated manner so that a reliable,leakage proof connection is created between prosthesis 40 and the bloodvessel. The medium is then released from balloon 200 again so that itcrimps and can be removed easily, whereafter the incision can be closedand the normal blood flow restarted. The patient is now ready for usualafter-care.

Further embodiments of a vascular prosthesis according to the inventionare shown in FIGS. 7 to 12. These embodiments form together with theabove described embodiments modules of a more extensive embodiment of avascular prosthesis system according to the invention.

The vascular prosthesis of FIG. 7 was also shown in FIG. 6B andcomprises a flexible tubular body with a main leg 45 between the freeends of which at least one and in this case two side legs 46 extend. Thefree ends of the main leg are herein provided with an internal annularbody 10 forming part of the suturing means of the type of FIGS. 5A and5B which lies on an outer wall of the prosthesis. Both side legs areprovided on their ends with coupling means 90 which are capable of an atleast practically liquid-tight rapid coupling to a free end of a secondflexible tubular body 80 of a second vascular prosthesis.

The coupling means are shown in cross-section in more detail in FIGS. 8Aand 8B and comprise per side leg 46 a cylindrical coupling element 90which is firmly connected by means of a suitable glue connection to therelevant side leg. On a free end the coupling element 90 comprises aslightly conically tapering taper 91 for receiving thereon the free endof the second vascular prosthesis 80. The coupling element here has aninternal diameter practically equal to that of vascular prostheses 40,80so that the blood flow thereof encounters hardly any obstacle.

A mutual connection of both prostheses can be effected simply, rapidlyand reliably by sliding the free end of the second vascular prosthesis80 over taper 91 such that it is clamped fast. Thus achieved is thecoupling of FIG. 8B which has already been found extremely reliable inpractice. However, in order to further ensure the connection a crimpring can optionally be placed round the end of the second vascularprosthesis 80 at the position of taper 91 and can be crimped thereon atincreased temperature. The shear resistance of the second vascularprosthesis can be further increased by also providing the taper with oneor more tangentially running ribs or an otherwise wrinkled or roughsurface. In all cases the advantage of a liquid-tight rapid couplingbetween the two vascular prostheses 40,80 is retained.

The modular embodiment of the vascular prosthesis shown in FIG. 7 isextremely suitable for a double end-to-end or end-to-side anastomosiswherein an incision is made in a main blood vessel for introducingtherein of the main leg 45 of the prosthesis. Main leg 45 issubsequently sutured in the main blood vessel as described withreference to FIGS. 6A and 6B, and clamped by means of two externalannular bodies 20. Side legs 46 can then each be coupled to an end of afurther blood vessel. For this purpose use is made of intermediateprostheses, for instance of the type shown in FIG. 9. These prostheseseach comprise a free end and an internal annular body 10 on the otherend for suturing to a blood vessel end and form a further module of theprosthesis system. Once both intermediate prostheses, after optionallybeing shortened to a desired length, are connected to the blood vesselend, the free end is pushed over coupling element 90 to thus complete adouble end-to-side anastomosis. The prosthesis of FIG. 9 can otherwisealso be deployed per se for a simple end-to-end anastomosis wherein theone end is connected to a first blood vessel end and the free end, withor without interposing of a comparable prosthesis provided with couplingmeans, is coupled to a second end of the blood vessel. In a variation ofthis prosthesis (module), the free end is provided with coupling means,which enables a linear extension of free-ending vascular prostheses.

For a multiple end-to-end anastomosis use can advantageously be made ofthe vascular prosthesis according to the invention shown in FIG. 10which forms a further module in the prosthesis system. This prosthesiscomprises a main leg 45 having on one side a free end which can becoupled to coupling means of another module and on the other side aninternal annular body 10 forming part of the suturing means according toan embodiment of the invention. Connected to the main leg between bothends is a side leg 46 which likewise carries such an internal annularbody 10 on its end. By means of these bodies 10 the prosthesis can besutured to respective ends of a first and second end of the first bloodvessel or coupling to an intermediate prosthesis which is sutured tothis second end and provided on a free end with coupling means accordingto the invention.

A single end-to-side anastomosis in a blood vessel 50 is shown in FIG.11. Use is made for this purpose of a further embodiment of the vascularprosthesis according to the invention which forms a correspondingfurther module in the prosthesis system. This prosthesis is sutured inand on a blood vessel in similar manner to the prosthesis of FIG. 7 andherein provides a single side leg 46 between both ends of the main leg45 received in blood vessel 50. The free end of side leg 46 can forinstance be coupled with the above stated variation of the prosthesis ofFIG. 9 to an end of a further blood vessel.

For support or even complete by-pass of a bifurcation use canadvantageously be made of the vascular prosthesis according to theinvention shown in FIG. 12 which thereby forms a further module withinthe prosthesis system according to the invention. This vascularprosthesis comprises a tubular body with a primary leg 47 which dividesat one end into two secondary legs 48. Making use of this module anaorta-bifemoral bypass can be performed in relatively simple manner.Primary leg 47 of the prosthesis is herein sutured with suturing means10 to the aorta abdominalis. From the two secondary legs 48 anend-to-end respectively end-to-side anastomosis to the arteria femoraliscan then be made with interposing of two prostheses of the type showneither in FIG. 9 or in FIG. 11. If desired, these second prostheses canherein each be individually shortened to a desired length and coupledwith the above described rapid coupling to the first vascularprosthesis. Such a prosthesis can also be deployed very practically fora bypass at a higher location between the aorta abdominalis and thearteria iliaca communis, as it can in the case of any other bifurcation.

Although the invention has been further described above solely withreference to a single embodiment, it will be apparent to all that theinvention is in no way limited to the given examples. On the contrary,many variations and embodiments are possible for the average skilledperson within the scope of the invention. The vascular prosthesis systemcan thus be extended with additional prosthesis modules, each for aspecific operation or for a similar type of surgery but with otherdimensions and/or couplings.

Many variations of the shown suturing means are also possible for anaverage skilled person without having to depart from the scope of theinvention. Different types of suturing member can thus be applied andthe internal and external annular bodies can also be manufactured fromother materials and can be designed or embodied differently. Moreparticularly the annular bodies can for instance be provided withperforations to enhance the acceptance and accommodation thereof in thebody.

For insertion and clamping of the prosthesis according to the inventionalternative devices can also be used instead of the described device andballoon, for instance a device with outward scissoring parts which canbe forced apart from a distance.

The invention generally provides a completely new surgical procedure inrespect of the processing of vascular prostheses which draws much lessheavily on the condition of the patient than the more conventionalsurgery.

1. Suturing means for connecting a tubular vascular prosthesis (40) to avessel (50) in a body, said suturing means comprising an internal,substantially annular member (10) intended to be received inside thevessel and an external annular member (20) intended to be applied aroundthe vessel essentially at the location of the internal annular member,in order to receive a vessel wall between both annular members, in whichat least one of the two annular members is provided with suturingmembers (20) which at, least in use, grip in the vessel wall, fixatingat least the internal annular member, characterized in that the internalannular member (10), at least in use, is firmly connected to an extremeend of the prosthesis, in that the internal annular member defines asealing surface extending substantially continuously over an annularcircumference of said internal annular member and in that the externalannular member, at least in use, substantially surrounds the internalannular member at least at an area of said sealing surface defined bysaid internal annular member, clamping the vessel wall there between ina substantially leak free manner.
 2. Suturing means as claimed in claim1, characterized in that the suturing members (12), at least in use,extend radially from a first of the two annular members (10, 20) and arereceived in the other of the two annular members (20, 10) in order toeffect a firm mutual connection while enclosing the wall of the vascularprosthesis (40) and the vessel wall (50).
 3. Suturing means as claimedin claim 2, characterized in that the first annular member comprises ametal ring (10) with lips (12) which can be pressed radially outward andare provided with sharp protrusions (13), which are capable ofpenetrating through the wall material of the prosthesis (40), throughthe wall of the vessel (50) and into the material of the other of thetwo annular members (20, 10).
 4. Suturing means as claimed in claim 3,characterized in that the protrusions (13) are provided with one or morebarbed hooks (14).
 5. Suturing means as claimed in claim 2 or 3 or 4,characterized in that the suturing members (12) extend from the internalannular member (10) and that the external annular member (20) comprisesat least a core of plastic for receiving the suturing members therein.6. Suturing means as claimed in claim 2, characterized in that the meansalso comprise a clamping ring (30) which, at least in use, lies againstan outer wall of the prosthesis (40) essentially at the position of theinternal annular member (10), exerting at least locally a radiallyinward directed force.
 7. Suturing means as claimed in claim 6,characterized in that the clamping ring comprises a crimp ring (30)which can permanently decrease in diameter at elevated temperature. 8.Suturing means as claimed in claim 1, characterized in that the suturingmembers (12) comprise protrusions (13) which protrude outward from theinternal annular member and are capable, at least under the influence ofa radially directed force, of penetrating at least partially in thevessel wall to anchor the prosthesis (40).
 9. Suturing means as claimedin claim 8, characterized in that the suturing members (12) comprise aregular pattern of crater-like openings (14), the walls (15) of whichform of protrusions (13).
 10. Suturing means as claimed in any of claim8 or 9, characterized in that the internal annular member (10) has aninner diameter which is at least practically equal to an outer diameterof the vascular prosthesis (40) and that the internal annular member isintended to lie against an outer wall of the vascular prosthesis. 11.Suturing means as claimed in claim 8, characterized in that the internalannular member (10) comprises a deformable ring which in a firstcontracted state has a diameter which falls within the diameter of thevessel (50) and in a second expanded state is able to lie against aninner wall of the vessel.
 12. Suturing means as claimed in claim 1,characterized in that the external annular member (20) comprises a ringwhich comprises an interruption in at least one position and that at thelocation of the interruption (21) closing means (22, 23) are provided tomutually connect adjacent ring parts.
 13. Suturing means as claimed inclaim 1, characterized in that the external annular member (20)comprises at least internally a regular pattern of cams (24) intended tobe received on the vessel wall, and in that said cams mutually leavefree interspaces (25), which extend over a full width of the member. 14.Vascular prosthesis comprising a flexible tubular body (40) of which atleast a first end is intended to be connected to a vessel (50),characterized in that the tubular body is provided on at least the firstend with the internal annular member (10) of the suturing means asclaimed in claim
 1. 15. Vascular prosthesis as claimed in claim 14,characterized in that at the location of the internal annular member(10) a clamping ring (30) lies clampingly on an outer wall of thetubular body (40) while enclosing the wall of the tubular body. 16.Vascular prosthesis as claimed in claim 14, characterized in that theinternal annular member (10) lies on an outer wall of the tubular body(40) via a suitable glue connection.
 17. Vascular prosthesis as claimedin claim 14 or 15 or 16, characterized in that a second end of thetubular body (40) is provided with coupling means (70) which are capableof a liquid-tight coupling to a free end of a further vascularprosthesis (80).
 18. Vascular prosthesis as claimed in claim 17,characterized in that the coupling means (70) comprise a rigid, tubularcoupling element (90) which is firmly connected on a first side to thesecond end of the tubular body (40) and comprises on a second side atapered portion (91) intended for clampingly receiving said free end ofsaid further vascular prosthesis (80).
 19. Vascular prosthesis asclaimed in claim 15, characterized in that said tapered portioncomprises a rib which extends over at least a part of an outer peripheryof the tapered portion.
 20. Vascular prosthesis as claimed in claim 19,characterized in that the coupling element (90) comprises at thelocation of the tapered portion (91) at least two external ribs whichleave a certain interspace, which interspace is intended for receiving aclamping ring (30) which fixedly clamps the free end of the furthervascular prosthesis (80) onto the tapered portion (91).
 21. Vascularprosthesis as claimed in claim 14, characterized in that the tubularbody (40) comprises a main leg (45), and at least one side leg (46)between opposite ends of said main leg (45), and that at least one ofthe free ends of the tubular body carries either the internal annularmember (10) associated with the suturing means as claimed in claim 1, orcoupling means (70) capable of a liquid-tight connection to a free endof a further vascular prosthesis (80).
 22. Vascular prosthesis asclaimed in claim 21, characterized in that the main leg (45) is providedon either side with an internal annular member (10).
 23. Vascularprosthesis as claimed in claim 21 or 22, characterized in that two sidelegs (46) extend from the main leg (45) which are each provided on afree end with coupling means (70).
 24. Vascular prosthesis as claimed inclaim 14, characterized in that the tubular body (40) comprises aprimary leg (47) with a first free end and a second end which dividesinto at least two secondary legs (48), each providing the tubular bodywith a further free end, and that at least one free end of the tubularbody carries either the internal annular member (10) associated with thesuturing means as claimed in claim 1, or coupling means (70) capable ofa liquid-right connection to a free end of a further vascular prosthesis(80).
 25. Vascular prosthesis as claimed in claim 24, characterized inthat the primary leg (47) is provided on the first end with the internalannular member (10) and that secondary legs (48) each carrying couplingmeans (70) on their further free end.
 26. Vascular prosthesis systemcomprising mutually connectable vascular prosthesis modules which eachcomprise a vascular prosthesis as claimed in claim 14.